Tracking Physical Activity Throughout Chemotherapy for Breast Cancer

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT03041545
Collaborator
National Cancer Institute (NCI) (NIH)
32
1
32.3
1

Study Details

Study Description

Brief Summary

Physical activity during chemotherapy has been shown to increase patient health and wellbeing as well as improve outcomes in breast cancer patients. The primary aim of this project is to determine the feasibility of incorporating wearable sensors into clinical care by having breast cancer patients, undergoing chemotherapy, wear a commercially available monitor (Fitbit) that tracks physical activity, sleep, and heart rate monitor.

Condition or Disease Intervention/Treatment Phase
  • Device: Fitbit

Detailed Description

Although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment. Existing research has primarily relied on self-reported activity levels and only captured periodic snap shots or retrospective reports of activity levels, which are subject to recall bias. Exactly how activity levels change throughout chemotherapy is not known. This study will provide minute-by-minute level objective physical activity data across the entirety of the patient's chemotherapy treatments. This in depth data will provide a new perspective on the patterns of activity levels and help to identify if there are critical times in which to intervene to prevent declines in physical activity.

The investigators will assess the feasibility of the pre-treatment recruitment by documenting recruitment rates and participant acceptance of wearing the accelerometer.

Study Design

Study Type:
Observational
Actual Enrollment :
32 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tracking Physical Activity Throughout Chemotherapy for Breast Cancer
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Feb 8, 2018
Actual Study Completion Date :
Feb 8, 2018

Arms and Interventions

Arm Intervention/Treatment
Fitbit

All participants will be asked to wear the Fitbit as much as possible and to sync it at least once a week, from one week prior to start of chemotherapy treatment to six months after ending chemotherapy.

Device: Fitbit
Women enrolled in the study will be asked to wear a Fitbit from one week prior to chemotherapy until six months post-chemotherapy. The Fitbit is a watch-sized, wrist worn, physical activity tracker. A button, when pressed, displays the wearer's accumulated daily steps, mileage, and steps climbed.

Outcome Measures

Primary Outcome Measures

  1. Recruitment [06/01/2015-06/01/2018]

    Enrolling >20% of eligible patients

Secondary Outcome Measures

  1. Retention [From date enrolled into the study until 1 week after the date of the last infusion center visit for chemotherapy, which is typically up to 6 months.]

    >80% of participants wore the Fitbit for >80% of the days during chemotherapy treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 85 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Female

  • Diagnosed with breast cancer

  • Scheduled to receive chemotherapy, but has not yet started chemotherapy

  • Receiving chemotherapy at a University of California, San Diego clinic

  • Willingness to wear the Fitbit throughout the course of chemotherapy

  • Access to a computer or Bluetooth enabled phone to sync Fitbit data

  • Able to read and communicate in English

Exclusion Criteria:

• Serious physical limitation that greatly limits mobility

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Diego La Jolla California United States 92093

Sponsors and Collaborators

  • University of California, San Diego
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sheri J Hartman, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheri Hartman, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT03041545
Other Study ID Numbers:
  • 150860
  • 5U54CA155435-05
First Posted:
Feb 2, 2017
Last Update Posted:
Jun 12, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2018